HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 

Medical Policy:
S-141-019
Topic:
Ablation of Liver Tumors
Section:
Surgery
Effective Date:
February 5, 2024
Issued Date:
February 5, 2024
Last Revision Date:
December 2023
Annual Review:
December 2023
 
 

Radiofrequency ablation (RFA) is a procedure in which a probe is inserted into the center of a tumor and heated locally by a high frequency, alternating current that flows from electrodes. The local heat treats the tissue adjacent to the probe, resulting in a 3-5 cm sphere of dead tissue. The cells killed by RFA are not removed but are gradually replaced by fibrosis and scar tissue. RFA may be performed percutaneously, laparoscopically, or as an open procedure.

Cryosurgical ablation involves the freezing of target tissues, most often by inserting a probe into the tumor where coolant is circulated. Cryosurgical ablation can be performed as an open surgical technique or percutaneously or laparoscopically, typically with ultrasound guidance.

Microwave ablation (MWA) destroys tumors using microwave energy to generate thermal coagulation and localized tissue necrosis with minimal damage to surrounding tissues. MWA may be performed percutaneously, laparoscopically, or as an open procedure.

Policy Position

RFA or MWA primary or metastatic hepatocellular carcinoma (HCC) may be considered medically necessary in individuals who are not surgical candidates when ANY of following are met: 

  • There are no more than three (3) nodules and all tumor foci can be adequately treated; or
  • As a bridge to transplant when ALL of the following criteria have been met:
    • Preserved liver function defined as Child-Pugh Class A or B; and
    • Single  tumors less than or equal to 6.5 cm in diameter, or no more than three (3) lesions less than or equal to 4.5 cm in diameter, and total tumor diameter less than or equal to 8 cm ; and
    • No evidence of extra-hepatic metastases; and
    • No evidence of portal vein occlusion; or
  • Primary or metastatic treatment of hepatic metastases five (5) cm or less in diameter from colorectal cancer in the absence of extrahepatic metastatic disease when all tumor foci can be adequately treated; or
  • Treatment of hepatic metastases from neuroendocrine tumors in individuals with symptomatic disease when systemic therapy has failed to control symptoms; or
  • As a repeat procedure when at least six (6) months have elapsed since the prior surgical resection or ablation.

RFA or MWA for hepatic metastasis is considered experimental/investigational for the following:

  • Hepatic metastases from colorectal cancer or neuroendocrine tumors that do not meet the criteria above; and
  • Hepatic metastases from other types of cancer with the exception of colorectal cancer or neuroendocrine tumors.

RFA or MWA of liver tumors not meeting the criteria as indicated in this policy is considered experimental/investigational  because the safety/and or effectiveness of this service cannot be established by the available published peer-reviewed literature.

47370

47380

47382

76940

 

 

 




Cryosurgical ablation of the liver, using a United States Food and Drug Administration (U.S. FDA) approved cryosurgical device, may be considered medically necessary for select individuals with unresectable liver tumors or for individuals whose liver tumors are not totally resectable when ALL of the following criteria are met:

  • Proven primary or secondary malignant tumor by biopsy, tumor markers, MRI, CT scan or ultrasound; and
  • The lesion(s) must be unresectable, whether on the basis of size, location, (proximity to major structures) bilobar involvement, or underlying liver disease (such as cirrhosis); and
  • For individuals with metastatic disease there must be no residual tumor at the primary site; and
  • There must be no evidence of extrahepatic malignancy; and 
  • All visible tumors (visible by imaging study including intraoperative ultrasound) must be eradicable; and
  • Lesion measures no more than 4 cm in diameter; and
  • Lesions must be either a primary hepatocellular carcinoma or hepatic metastases from either primary colorectal cancer or neuroendocrine cancer. 

The following uses of cryosurgical ablation of the liver are considered experimental/investigational:

  • When policy criteria have not been met; or
  • Metastatic lesions of the liver are from tumor primaries other than colorectal or neuroendocrine cancer.

The use of cryosurgical ablation for liver tumors not meeting the criteria as indicated in this policy is considered experimental/investigational because the safety and/or effectiveness of this service cannot be established by the available peer-reviewed literature. 

47371

47381

47383

76940

 

 

 




Related Policies

Refer to Medical Policy S-137, Radiofrequency Ablation of Miscellaneous Solid Tumors Excluding Liver Tumors, for additional information. 


Professional Statements and Societal Positions Guidelines

National Institute for Health and Care Excellence (NICE) 2016

Microwave ablation for treating liver metastases recommendations:

  • Current evidence on microwave ablation for treating liver metastases raises no major safety concerns and the evidence on efficacy is adequate in terms of tumour ablation. Therefore this procedure may be used provided that standard arrangements are in place for clinical governance, consent and audit.
  • Patient selection should be carried out by a hepatobiliary cancer multidisciplinary team.
  • Further research would be useful for guiding selection of patients for this procedure. This should document the site and type of the primary tumour being treated, the intention of treatment (palliative or curative), imaging techniques used to assess the efficacy of the procedure, long-term outcomes and survival.

National Comprehensive Cancer Network (NCCN) 2023

I. General Principles

• All patients with HCC should be evaluated for potential curative therapies (resection, transplantation, and for small lesions, ablative strategies).

 Locoregional therapy should be considered in patients who are not candidates for surgical curative treatments, or as a part of a strategy to bridge patients for other curative therapies. These are broadly categorized into ablation, arterially directed therapies, and radiotherapy.

II. Treatment Information

A. Ablation (radiofrequency, cryoablation, percutaneous alcohol injection, microwave):

• All tumors should be amenable to ablation such that the tumor and, in the case of thermal ablation, a margin of normal tissue is treated.

A margin is not expected following percutaneous ethanol injection.

• Tumors should be in a location accessible for percutaneous/laparoscopic/open approaches for ablation.

• Caution should be exercised when ablating lesions near major vessels, major bile ducts, diaphragm, and other intra-abdominal organs.

• Ablation alone may be curative in treating tumors less than or equal to 3 cm. In well-selected patients with small properly located tumors, ablation should be considered as definitive treatment in the context of a multidisciplinary review. Lesions 3 to 5 cm may be treated to prolong survival using arterially

directed therapies, or with combination of an arterially directed therapy and ablation as long as tumor location is accessible for ablation.

• Unresectable/inoperable lesions greater than 5 cm should be considered for treatment using arterially directed therapy, systemic therapy, or RT.4-6

• Currently, no adjuvant therapies have been shown to have added value post-ablation.


Covered Diagnosis Codes for Procedure Codes 47370, 47380, 47382, 47371, 47381, and 47383

C22.0

C22.2

C22.3

C22.4

C22.7

C22.8

C22.9

C78.7

C7B.02

C7B.1

D01.5

D37.6

 

 

 



Place of Service: Inpatient/Outpatient

Experimental/Investigational (E/I) services are not covered regardless of place of service.

Ablation of Liver Tumors is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.



The policy position applies to all commercial lines of business



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This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical or other circumstances may warrant individual consideration, based on review of applicable medical records, as well as other regulatory, contractual and/or legal requirements.

Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
    • Qualified sign language interpreters
    • Written information in other formats (large print, audio, accessible electronic formats, other formats)
  • Provides free language services to people whose primary language is not English, such as:
    • Qualified interpreters
    • Information written in other languages

If you need these services, contact the Civil Rights Coordinator.

If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)

Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.

This information is issued by Highmark Blue Shield on behalf of its affiliated Blue companies, which are independent licensees of the Blue Cross Blue Shield Association.  Highmark Inc. d/b/a Highmark Blue Shield and certain of its affiliated Blue companies serve Blue Shield members in the 21 counties of central Pennsylvania. As a partner in joint operating agreements, Highmark Blue Shield also provides services in conjunction with a separate health plan in southeastern Pennsylvania.  Highmark Inc. or certain of its affiliated Blue companies also serve Blue Cross Blue Shield members in 29 counties in western Pennsylvania, 13 counties in northeastern Pennsylvania, the state of West Virginia plus Washington County, Ohio, the state of Delaware[ and [8] counties in western New York and Blue Shield members in [13] counties in northeastern New York].  All references to Highmark in this document are references to Highmark Inc. d/b/a Highmark Blue Shield and/or to one or more of its affiliated Blue companies.





Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
  • Qualified sign language interpreters
  • Written information in other formats (large print, audio, accessible electronic formats, other formats)

  • Provides free language services to people whose primary language is not English, such as:
  • Qualified interpreters
  • Information written in other languages
  • If you need these services, contact the Civil Rights Coordinator.

    If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295 , TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

    You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

    U.S. Department of Health and Human Services
    200 Independence Avenue, SW
    Room 509F, HHH Building
    Washington, D.C. 20201
    1-800-368-1019, 800-537-7697 (TDD)

    Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.